RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy

Not Applicable

Not yet recruiting

• Conditions: Achilles Tendinopathy
• Interventions: Other: Formal Physical Therapy; Other: Home-based Exercise Protocol

• Registration Number: NCT06374654
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Must be 18 years of age
• Must have a new diagnosis of Achilles tendinopathy that has presented with pain, thickening and tenderness at the mid substance of the Achilles tendon
• Symptoms present for at least 6 weeks

Exclusion Criteria

• Patients with insertional Achilles pain or tenderness or concomitant plantar foot pain
• Patients who have had prior treatment with home eccentric stretching or physical therapy
• Patients who have prior diagnosis and treatment for Achilles tendinopathy
• Patients with history of injection (corticosteroid or sclerosing agents) to the Achilles tendon
• Patients with inflammatory arthritis
• Recent fluoroquinolone antibiotics (these agents are known to alter Achilles tendon physiology)
• Patients who have had prior foot or ankle surgery
• Individuals that do not speak English
• Bilateral disease
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formal Physical Therapy Protocol	Formal Physical Therapy	-
Home-based Protocol	Home-based Exercise Protocol	-

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)	Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment	Achilles tendon-specific questionnaire that asks about patient pain, functional status, and activity level.

Secondary Outcome Measures

Name	Time	Method
PROMIS Depression (4a)	Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
PROMIS Pain Interference (4a)	Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
PROMIS Pain Intensity (3a)	Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Patient Acceptable Symptom State Questionnaire	Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States